In response to a request for comments from the Food and Drug Administration (FDA) regarding new rules regulating over-the-counter hearing aids, NAAG submitted comments encouraging the FDA to take the below steps to ensure that states maintain a role as regulators in this emerging market:
- The FDA should define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.
- The FDA should state explicitly the type of state requirements that the final rule would not preempt.
- Lastly, the FDA should explicitly state in the final OTC Rule: (a) that the existing processes in place in 21 C.F.R. §808.20 to petition the FDA for a preemption determination will continue to apply, and (b) that the FDA will find against preemption when consistent with the statutory language and “in the public interest.”
**This letter was updated on January 18, 2022, to reflect all attorney general offices that signed the letter.